Table 1.
Demographics at baseline of the randomly assigned, exposed population (safety set) and the per-protocol population
|
Safety set |
Per-protocol population |
|||||
|---|---|---|---|---|---|---|
| Total (n=30 128) | SCB-2019 (n=15 064) | Placebo (n=15 064) | SCB-2019 (n=6251) | Placebo (n=6104) | ||
| Sex | ||||||
| Male | 16 009 (53·1%) | 7978 (53·0%) | 8031 (53·3%) | 3392 (54·3%) | 3391 (55·6%) | |
| Female | 14 119 (46·9%) | 7086 (47·0%) | 7033 (46·7%) | 2859 (45·7%) | 2713 (44·4%) | |
| Mean age, years | 32·1 (18–86) | 32·1 (18–86) | 32·0 (18–81) | 31·2 (18–79) | 31·0 (18–80) | |
| Age group | ||||||
| ≥18 to 64 | 29 712 (98·6%) | 14 863 (98·7%) | 14 849 (98·6%) | 6197 (99·1%) | 6040 (99·0%) | |
| ≥65 to 74 | 366 (1·2%) | 176 (1·2%) | 190 (1·3%) | 49 (0·8%) | 55 (0·9%) | |
| ≥75 | 50 (0·2%) | 25 (0·2%) | 25 (0·2%) | 5 (0·1%) | 9 (0·1%) | |
| At a high risk of severe COVID-19* | 5463 (18·1%) | 2769 (18·4%) | 2694 (17·9%) | 1068 (17·1%) | 992 (16·3%) | |
| Hispanic or Latino ethnicity | ||||||
| Hispanic or Latino | 13 726 (45·6%) | 6857 (45·5%) | 6869 (45·6%) | 3356 (53·7%) | 3224 (52·8%) | |
| Not Hispanic or Latino | 15 875 (52·7%) | 7950 (52·8%) | 7925 (52·6%) | 2767 (44·3%) | 2759 (45·2%) | |
| Not reported and unknown | 527 (1·7%) | 257 (1·7%) | 270 (1·8%) | 128 (2·0%) | 121 (2·0%) | |
| Race | ||||||
| American Indian† or Alaskan Native | 6544 (21·7%) | 3274 (21·7%) | 3270 (21·7%) | 1294 (20·7%) | 1252 (20·5%) | |
| Asian | 13 720 (45·5%) | 6852 (45·5%) | 6868 (45·6%) | 2230 (35·7%) | 2200 (36·0%) | |
| Black or African American | 2979 (9·9%) | 1519 (10·1%) | 1460 (9·7%) | 716 (11·5%) | 705 (11·5%) | |
| Native Hawaiian or Pacific Islander | 7 (<0·1%) | 4 (<0·1%) | 3 (<0·1%) | 2 (<0·1%) | 2 (<0·1%) | |
| White | 6098 (20·2%) | 3022 (20·1%) | 3076 (20·4%) | 1829 (29·3%) | 1759 (28·8%) | |
| Other | 176 (0·6%) | 91 (0·6%) | 85 (0·6%) | 46 (0·7%) | 47 (0·8%) | |
| Unknown or not reported | 604 (2·0%) | 302 (2·0%) | 302 (2·0%) | 134 (2·1%) | 139 (2·3%) | |
| Baseline SARS-CoV-2 status | ||||||
| Negative | 14 993 (49·8%) | 7483 (49·7%) | 7510 (49·9%) | 6251 (100%) | 6104 (100%) | |
| Positive | 14 622 (48·5%) | 7315 (48·6%) | 7307 (48·5%) | 0 | 0 | |
| Missing data | 513 (1·7%) | 266 (1·8%) | 247 (1·6%) | 0 | 0 | |
| Known history of COVID-19 at baseline | ||||||
| No | 28 522 (94·7%) | 14 259 (94·7%) | 14 263 (94·7%) | 6251 (100·0%) | 6104 (100·0%) | |
| Yes | 1602 (5·3%) | 802 (5·3%) | 800 (5·3%) | 0 | 0 | |
| Missing | 4 (<0·1%) | 3 (<0·1%) | 1 (<0·1%) | 0 | 0 | |
| Country | ||||||
| Belgium (3 sites) | 709 (2·4%) | 354 (2·3%) | 355 (2·4%) | 255 (4·1%) | 277 (4·5%) | |
| Brazil (5 sites) | 7947 (26·4%) | 3973 (26·4%) | 3974 (26·4%) | 2258 (36·1%) | 2153 (35·3%) | |
| Colombia (9 sites) | 6696 (22·2%) | 3348 (22·2%) | 3348 (22·2%) | 1330 (21·3%) | 1294 (21·2%) | |
| Philippines (10 sites) | 13 676 (45·4%) | 6834 (45·4%) | 6842 (45·4%) | 2218 (35·5%) | 2177 (35·7%) | |
| South Africa (4 sites) | 1100 (3·7%) | 555 (3·7%) | 545 (3·6%) | 190 (3·0%) | 203 (3·3%) | |
Data shown as number of participants (%) or mean (range).
*
Risk because of the presence of known comorbidities, including: asthma, cancer, chronic kidney disease, chronic artery disease, cardiomyopathy, type 1 or 2 diabetes, heart failure, chronic obstructive pulmonary disease, hypertension or high blood pressure, immunocompromised, liver disease, obesity with a body-mass index of 30 kg/m2 or more, sickle cell disease, living with HIV, and substance abuse disorders.
†
Refers to Indigenous peoples of Colombia.